by Hélène Mauduit
BERLIN, Dec 29 (APM) - Three drugs which had been withdrawn from the German market made a comeback in 2017, the first time this had happened since the AMNOG pricing law was implemented in 2011.
Astellas's Betmiga (mirabegron) in overactive bladder was reintroduced in August (APMMA 54121), followed by AstraZeneca's cancer drug Tagrisso (osimertinib) in November (APMMA 55236) and Eisai's epilepsy drug Fycompa (perampanel) (APMMA 55797).
At the same time, only one drug - Shionogi's Senshio (ospemifen) - was withdrawn from the market due to pricing issues after two 'record' years - seven withdrawals in 2015 and eight in 2016, according to APM's records.
The withdrawals were due to unsatisfactory pricing after 'no added benefit' ratings from health technology assessment (HTA) body G-BA.
Tagrisso (osimertinib) was withdrawn only a year previously and was reintroduced because of a positive reassessment. New pricing negotiations are ongoing.
Betmiga returned to Germany two years after being withdrawn, without any new pricing negotiations, whereas Fycompa was reintroduced after four years thanks to new price discussions.
Eisai then filed Fycompa for assessment in an extended indication granted in June 2015 and not previously evaluated by G-BA, as an adjunctive treatment for primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.
31 launches, 50 ratings
According to pharma lobby vfa, 31 new drugs (excluding biosimilars) were launched in Germany in 2017, exactly the same number as in 2016. Nine of these were orphan drugs.Among the launches, eleven drugs are indicated in cancer, 10 are for inflammatory diseases, four for infectious diseases, two for blood diseases, two in neurology, one for cardiovascular disease and one for metabolic diseases, vfa said in a statement .
Four biosimilars were also launched in Germany in 2017, after just one in 2016 (Biogen's Benepali, a biosimilar of Amgen/Pfizer's Enbrel).
These were two biosimilar versions of Roche's MabThera (rituximab), Mundipharma's Truxima and Hexal's Rixathon (APMMA 53871); one biosimilar of Lilly's Humalog (insulin lispro), Sanofi's Insulin Lispro Sanofi (APMMA 54568); and one of Enbrel (etanercept), Hexal's Erelzi (APMMA 53871).
In 2017 G-BA published 50 rulings, including 14 on orphan drugs. Thirty-three procedures, including 10 for orphan drugs, are ongoing.
Three drugs were exempted from HTA in 2017 because the expected expenditure on them was considered negligible, a situation which has occurred only nine times since 2011.
These were Amomed's Rapibloc (landiolol), indicated for the treatment of supraventricular tachycardia; Eusa's Dinutuximab beta EUSA (dinutuximab beta) for the treatment of high-risk neuroblastoma; and Advanced Accelerator Applications' Lutathera (lutetium-oxodotreotid), a metabolic radiotherapy approved in the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
In the case of Rapibloc, G-BA started an assessment (APMMA 54528) which was disputed by Amomed (APMMA 54603), and G-BA finally exempted the drug in October.
2018
Any decision-making in German drug policy is now suspended until the conclusion of negotiations between the conservative parties CDU and CSU and social democrats SPD to form a government coalition.Negotiations between the CDU/CSU and SPD began after the failure of earlier talks aiming to form a different coalition in November (APMMA 55667). They will continue at least until the end of January.
Drug policy is not a core subject in discussions on health policy in Germany, which are focused on the SPD's demand to create a "citizens' insurance" to replace the current statutory and private health insurance schemes.
Many changes to HTA and drug pricing law AMNOG have already been introduced in the drugs care reinforcement law (AM-VSG), which was passed in May (APMMA 53072), and many are already being applied by G-BA (APMMA 55750).
However G-BA's chair, Josef Hecken, has called for further changes to tighten up assessment of orphan drugs and drugs approved with insufficient evidence, or to restrict the prescription of these drugs (APMMA 55091).
Several pharma companies have criticised G-BA's methodology, especially for cancer drugs, but Hecken responded that G-BA will continue on the same path (APMMA 55737).
Pharma companies are also waiting with concern to see how the new "doctors' information system" (AIS) will be implemented. The writing of the regulation for this scheme, which was supposed to be published by the end of 2017, has been delayed, partly due to the political situation.
The legality of "mixed prices" for drugs with mixed added benefit ratings is a pending issue (APMMA 53716). The German federal social court will make a definitive ruling, but it is still unclear when this will take place. However, some lawyers say the question may be settled as early as 2018.
hm/clg
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